COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study
COVID‐19 vaccination is critical in frequently immunocompromised patients with rheumatoid arthritis (RA). However, there is a question about the risk of RA flares following vaccination. Our study intended to find out about cases of new RA or flare‐ups in people who already had RA that were reported...
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| Veröffentlicht in: | Clinical pharmacology and therapeutics 2023-05, Vol.113 (5), p.1107-1116 |
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| creator | Prontskus, Viktoryia Fresse, Audrey Yelehe‐Okouma, Mélissa Facile, Anthony Pietri, Tessa Simon, Corinne Le Souder, Cosette Beurrier, Mathilde Gillet, Pierre |
| description | COVID‐19 vaccination is critical in frequently immunocompromised patients with rheumatoid arthritis (RA). However, there is a question about the risk of RA flares following vaccination. Our study intended to find out about cases of new RA or flare‐ups in people who already had RA that were reported in French and international pharmacovigilance databases after COVID‐19 vaccination. We performed a “case–noncase” method in the international pharmacovigilance database VigiBase to identify the risk of RA following COVID‐19 vaccination compared with other nonlive vaccines. Using the French Pharmacovigilance Database (FPVD), a descriptive analysis was carried out for RA cases after COVID‐19 immunization and a multivariate logistic regression analysis was conducted to compare variables in the new‐onset vs. flare‐up groups. In 2021, 2,387 cases of RA were reported from 2,817,902 adverse drug reactions associated with COVID‐19 vaccines recorded in VigiBase. The reporting odds ratio of RA onset with COVID‐19 vaccines compared with the other nonlive vaccines was 0.66 (P |
| doi_str_mv | 10.1002/cpt.2866 |
| format | Article |
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However, there is a question about the risk of RA flares following vaccination. Our study intended to find out about cases of new RA or flare‐ups in people who already had RA that were reported in French and international pharmacovigilance databases after COVID‐19 vaccination. We performed a “case–noncase” method in the international pharmacovigilance database VigiBase to identify the risk of RA following COVID‐19 vaccination compared with other nonlive vaccines. Using the French Pharmacovigilance Database (FPVD), a descriptive analysis was carried out for RA cases after COVID‐19 immunization and a multivariate logistic regression analysis was conducted to compare variables in the new‐onset vs. flare‐up groups. In 2021, 2,387 cases of RA were reported from 2,817,902 adverse drug reactions associated with COVID‐19 vaccines recorded in VigiBase. The reporting odds ratio of RA onset with COVID‐19 vaccines compared with the other nonlive vaccines was 0.66 (P < 0.0001). The FPVD reported 161 cases of RA with COVID‐19 vaccines, including 77 new‐onset RA and 84 cases of RA flare‐up. In 88 cases (84.7%), RA occurred after the first dose. The mean time between vaccination and disease onset was 14 ± 21 days, and the delay was significantly shorter in the flare‐up group. We do not show a higher risk of RA after COVID‐19 vaccination compared with other nonlive vaccines in adults. De novo RA was more likely to happen quickly, be more severe, and have a worse outcome than flares in patients with RA.</description><identifier>ISSN: 0009-9236</identifier><identifier>EISSN: 1532-6535</identifier><identifier>DOI: 10.1002/cpt.2866</identifier><identifier>PMID: 36752604</identifier><language>eng</language><publisher>United States</publisher><subject>Adult ; Arthritis, Rheumatoid - drug therapy ; Arthritis, Rheumatoid - epidemiology ; COVID-19 - epidemiology ; COVID-19 - prevention & control ; COVID-19 Vaccines - adverse effects ; Humans ; Incidence ; Vaccination - adverse effects ; Vaccines</subject><ispartof>Clinical pharmacology and therapeutics, 2023-05, Vol.113 (5), p.1107-1116</ispartof><rights>2023 The Authors. © 2023 American Society for Clinical Pharmacology and Therapeutics.</rights><rights>2023 The Authors. 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However, there is a question about the risk of RA flares following vaccination. Our study intended to find out about cases of new RA or flare‐ups in people who already had RA that were reported in French and international pharmacovigilance databases after COVID‐19 vaccination. We performed a “case–noncase” method in the international pharmacovigilance database VigiBase to identify the risk of RA following COVID‐19 vaccination compared with other nonlive vaccines. Using the French Pharmacovigilance Database (FPVD), a descriptive analysis was carried out for RA cases after COVID‐19 immunization and a multivariate logistic regression analysis was conducted to compare variables in the new‐onset vs. flare‐up groups. In 2021, 2,387 cases of RA were reported from 2,817,902 adverse drug reactions associated with COVID‐19 vaccines recorded in VigiBase. The reporting odds ratio of RA onset with COVID‐19 vaccines compared with the other nonlive vaccines was 0.66 (P < 0.0001). The FPVD reported 161 cases of RA with COVID‐19 vaccines, including 77 new‐onset RA and 84 cases of RA flare‐up. In 88 cases (84.7%), RA occurred after the first dose. The mean time between vaccination and disease onset was 14 ± 21 days, and the delay was significantly shorter in the flare‐up group. We do not show a higher risk of RA after COVID‐19 vaccination compared with other nonlive vaccines in adults. De novo RA was more likely to happen quickly, be more severe, and have a worse outcome than flares in patients with RA.</description><subject>Adult</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Arthritis, Rheumatoid - epidemiology</subject><subject>COVID-19 - epidemiology</subject><subject>COVID-19 - prevention & control</subject><subject>COVID-19 Vaccines - adverse effects</subject><subject>Humans</subject><subject>Incidence</subject><subject>Vaccination - adverse effects</subject><subject>Vaccines</subject><issn>0009-9236</issn><issn>1532-6535</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc1O3DAQx60KVBZaiSeofKSHgD8Sx-G23YWyEoJqoXuNHHvCusrGW9sp2huPUKlv2Cch-wGcOI1m5qffSPNH6JiSU0oIO9PLeMqkEB_QgGacJSLj2R4aEEKKpGBcHKDDEH71bVpI-REdcJFnTJB0gP6NbmeT8f-nv7TAM6W1bVW0rsWqNTjOAU9abQ20GrCr8RjwjfvjsPN4CrrzHtqIp3PoFio6a_DQx7m30YZzPMSX_VbPN6JJG8FvxarBJzP7YL-pAF_xnX1YT8YQQW_O3sXOrD6h_Vo1AT7v6hH6eXlxP7pKrm-_T0bD60RzRkXCpSDAslqqSppKA6vTtGaZYJWhktPC5FyAkGmtac4p0TVRsqJGFgoykoqCH6GTrXfp3e8OQiwXNmhoGtWC60LJ8jxNi7wn31DtXQge6nLp7UL5VUlJuY6g7CMo1xH06JedtasWYF7Bl5_3QLIFHm0Dq3dF5ejH_Ub4DCupkF4</recordid><startdate>202305</startdate><enddate>202305</enddate><creator>Prontskus, Viktoryia</creator><creator>Fresse, Audrey</creator><creator>Yelehe‐Okouma, Mélissa</creator><creator>Facile, Anthony</creator><creator>Pietri, Tessa</creator><creator>Simon, Corinne</creator><creator>Le Souder, Cosette</creator><creator>Beurrier, Mathilde</creator><creator>Gillet, Pierre</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-7876-9846</orcidid><orcidid>https://orcid.org/0000-0002-7298-7065</orcidid><orcidid>https://orcid.org/0000-0002-3677-4919</orcidid></search><sort><creationdate>202305</creationdate><title>COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study</title><author>Prontskus, Viktoryia ; Fresse, Audrey ; Yelehe‐Okouma, Mélissa ; Facile, Anthony ; Pietri, Tessa ; Simon, Corinne ; Le Souder, Cosette ; Beurrier, Mathilde ; Gillet, Pierre</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3216-3860e25f8ab8dbce2f44f2562bd18319d736e684fc17310cf0a8b1d89ae504693</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Arthritis, Rheumatoid - drug therapy</topic><topic>Arthritis, Rheumatoid - epidemiology</topic><topic>COVID-19 - epidemiology</topic><topic>COVID-19 - prevention & control</topic><topic>COVID-19 Vaccines - adverse effects</topic><topic>Humans</topic><topic>Incidence</topic><topic>Vaccination - adverse effects</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Prontskus, Viktoryia</creatorcontrib><creatorcontrib>Fresse, Audrey</creatorcontrib><creatorcontrib>Yelehe‐Okouma, Mélissa</creatorcontrib><creatorcontrib>Facile, Anthony</creatorcontrib><creatorcontrib>Pietri, Tessa</creatorcontrib><creatorcontrib>Simon, Corinne</creatorcontrib><creatorcontrib>Le Souder, Cosette</creatorcontrib><creatorcontrib>Beurrier, Mathilde</creatorcontrib><creatorcontrib>Gillet, Pierre</creatorcontrib><creatorcontrib>French network of Regional Pharmacovigilance Centres</creatorcontrib><creatorcontrib>French network of Regional Pharmacovigilance Centres</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical pharmacology and therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Prontskus, Viktoryia</au><au>Fresse, Audrey</au><au>Yelehe‐Okouma, Mélissa</au><au>Facile, Anthony</au><au>Pietri, Tessa</au><au>Simon, Corinne</au><au>Le Souder, Cosette</au><au>Beurrier, Mathilde</au><au>Gillet, Pierre</au><aucorp>French network of Regional Pharmacovigilance Centres</aucorp><aucorp>French network of Regional Pharmacovigilance Centres</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study</atitle><jtitle>Clinical pharmacology and therapeutics</jtitle><addtitle>Clin Pharmacol Ther</addtitle><date>2023-05</date><risdate>2023</risdate><volume>113</volume><issue>5</issue><spage>1107</spage><epage>1116</epage><pages>1107-1116</pages><issn>0009-9236</issn><eissn>1532-6535</eissn><abstract>COVID‐19 vaccination is critical in frequently immunocompromised patients with rheumatoid arthritis (RA). However, there is a question about the risk of RA flares following vaccination. Our study intended to find out about cases of new RA or flare‐ups in people who already had RA that were reported in French and international pharmacovigilance databases after COVID‐19 vaccination. We performed a “case–noncase” method in the international pharmacovigilance database VigiBase to identify the risk of RA following COVID‐19 vaccination compared with other nonlive vaccines. Using the French Pharmacovigilance Database (FPVD), a descriptive analysis was carried out for RA cases after COVID‐19 immunization and a multivariate logistic regression analysis was conducted to compare variables in the new‐onset vs. flare‐up groups. In 2021, 2,387 cases of RA were reported from 2,817,902 adverse drug reactions associated with COVID‐19 vaccines recorded in VigiBase. The reporting odds ratio of RA onset with COVID‐19 vaccines compared with the other nonlive vaccines was 0.66 (P < 0.0001). The FPVD reported 161 cases of RA with COVID‐19 vaccines, including 77 new‐onset RA and 84 cases of RA flare‐up. In 88 cases (84.7%), RA occurred after the first dose. The mean time between vaccination and disease onset was 14 ± 21 days, and the delay was significantly shorter in the flare‐up group. We do not show a higher risk of RA after COVID‐19 vaccination compared with other nonlive vaccines in adults. De novo RA was more likely to happen quickly, be more severe, and have a worse outcome than flares in patients with RA.</abstract><cop>United States</cop><pmid>36752604</pmid><doi>10.1002/cpt.2866</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-7876-9846</orcidid><orcidid>https://orcid.org/0000-0002-7298-7065</orcidid><orcidid>https://orcid.org/0000-0002-3677-4919</orcidid></addata></record> |
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| ispartof | Clinical pharmacology and therapeutics, 2023-05, Vol.113 (5), p.1107-1116 |
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| subjects | Adult Arthritis, Rheumatoid - drug therapy Arthritis, Rheumatoid - epidemiology COVID-19 - epidemiology COVID-19 - prevention & control COVID-19 Vaccines - adverse effects Humans Incidence Vaccination - adverse effects Vaccines |
| title | COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study |
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